US OK's first-in-class drug Aimovig for migraine prevention

Henrietta Brewer
May 18, 2018

Erenumab is the first CGRP antagonist to be approved by the FDA for migraine prevention in adults.

It works "by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks", the FDA said in a statement.

The FDA has approved the first in a new class of migraine drugs, Novartis and Amgen's Aimovig, and at a lower than expected list price of $6,900.

"Cluster headache can be hard to evaluate in clinical studies, which has contributed to few available treatment options for clusterheadache, often considered the most severe pain one can experience", noted Christi Shaw, president of Lilly Bio-Medicines, in the release.

Around one in seven people worldwide experience migraines, among them 37 million Americans, the New York Times reported. Aimovig will be available in a pre-filled self-administering autoinjector, SureClick, for a once monthly 70 mg dosage.

Earlier in the week, Eli Lilly and Company (Indianapolis) announced that its CGRP monoclonal antibody, galcanezumab, met its primary endpoint in a Phase 3 study of patients with episodic cluster headache, which represents 85 to 90 percent of cluster headache cases, according to a company release. These drugs aim to block it cut down on the number of migraine days patients suffer each month. In this study, over the course of three months, patients treated with Aimovig experienced, on average, two and half fewer monthly migraine days than those receiving placebo.

Aimovig and the migraine drugs in development target a substance called CGRP whose levels spike in the blood during a migraine, triggering symptoms.

In addition to painkillers and triptans, which ease migraine effects when taken after one starts, preventative treatments for migraines already exist in the form of blood-vessel constrictors and Botox treatments. However, there were side-effects too - namely injection-site reactions and constipation.

Before the trial, patients had about 18 migraine days.

That's compared to the 2.15 and 1.85 day reduction that was observed in the placebo groups.

While out-of-pocket costs will vary depending on insurance status, the Aimovig Copay Program may be able to help reduce a patient's out-of-pocket costs to as little as USD5 per month for eligible patients with commercial insurance.

The second study included 577 patients with a history of episodic migraine and compared Aimovig to placebo.

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